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Trial record 1 of 2 for:    Boehringer Impulsivity
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Fingerprinting of Impulsivity

This study is currently recruiting participants.
Verified November 2017 by Boehringer Ingelheim
Sponsor:
ClinicalTrials.gov Identifier:
NCT02722174
First Posted: March 29, 2016
Last Update Posted: November 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
The study aims to examine a battery of behavioral and questionnaire measures in 4 disorders clinically associated with impulsivity and in health controls, to: 1) investigate if the different populations have a distinct behavioral profile, and 2) to investigate if there are specific measures that are reliable and sensitive measures of impulsivity across diagnoses.

Condition
Impulse Control Disorders

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fingerprinting of Impulsivity in Four Diagnostic and Statistical Manual of Mental Disorders, Version 5 (DSM-5) Psychiatric Disorders That Have Been Clinically Associated With Impulsivity Using a Battery of Questionnaires and Behavioral Laboratory Tests

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Go/No Go Task [ Time Frame: up to 5 weeks ]
  • Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Stop Signal Reaction Time (SSRT) Task [ Time Frame: up to 5 weeks ]
  • Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Computerized Monetary Choice Task [ Time Frame: up to 5 weeks ]
  • Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Barratt Impulsiveness Questionnaire version 11 (BIS-11) [ Time Frame: up to 5 weeks ]
  • Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Immediate Memory Task (IMT) [ Time Frame: up to 5 weeks ]
  • Stability in scores measured as change from baseline to follow-up visit at 4 (+/-1) weeks for Urgency, Premeditation, Perseverance, Sensation Seeking and Positive Urgency (UPPs-P) Impulsive Behavior Scale [ Time Frame: up to 5 weeks ]

Secondary Outcome Measures:
  • Antisaccade performance measured as change from baseline to follow-up visit at 4 (+/-1) weeks on the eye tracker [ Time Frame: up to 5 weeks ]

Estimated Enrollment: 240
Actual Study Start Date: July 22, 2016
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
BED
Binge Eating Disorder
ADHD
Attention Deficit Hyperactivity Disorder
SUD, cocaine subtype
Stimulant Use Disorder, cocaine subtype
BPD
Borderline Personality Disorder
BPD, Cohort 2
Borderline Personality Disorder, Cohort 2
HC
Healthy Controls

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
subjects meeting criteria for one of the described cohorts
Criteria

Inclusion criteria:

All cohorts:

- Males and females ages 18-50.

Healthy Control cohort:

- Volunteers in generally good Psychiatric and non-Psychiatric medical health

Borderline Personality Disorder (2 cohorts):

- Subjects who meet Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) criteria for Borderline Personality Disorder

Binge Eating Disorder cohort:

- Subjects who meet DSM-V criteria for Binge Eating Disorder.

Stimulant Use Disorder cohort:

- Subjects who meet DSM-V criteria for current Stimulant Use Disorder, subtype cocaine, moderate or severe use

Attention Deficit Hyperactivity Disorder cohort:

- Subjects who meet DSM-V criteria for adult Attention Deficit Hyperactivity Disorder

Exclusion criteria:

General:

  • Positive breathalyzer test for alcohol at any study visit
  • History of clinically significant neurologic disorders or head trauma with loss of consciousness greater than 30 minutes
  • Clinically significant non-psychiatric medical disorder requiring ongoing treatment as judged by the investigator.
  • Unwillingness or inability to sign a written informed consent form
  • Pregnancy as assessed by a urine test for ß-Human Chorionic Gonadotropin (ß-HCG) at screening visit
  • Medical or physical contraindications for participation (see below), based on medical history interview, as judged by the investigator
  • Unwilling to refrain from tobacco use one hour prior to testing until after conclusion of testing

Healthy Controls:

  • Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnoses of Personality Disorders (based on Structured Clinical Interview for DSM-IV (SCID)-II)
  • DSM-5 diagnoses based on the SCID-I (including the eating disorders and Attention Deficit Hyperactivity Disorder (ADHD) module)
  • History of arrest or incarceration
  • Positive urine drug screen for cannabis, cocaine, opioids, amphetamine, and benzodiazepines at any visit
  • Current Tobacco Users

Borderline Personality Disorder Subjects:

  • DSM-5 diagnoses other than: Tobacco Use Disorder, Major Depressive Disorder (Mild Subtype), Generalized Anxiety Disorder (in remission), Post-Traumatic Stress Disorder (in remission), Major Depressive Disorder (Moderate or Severe Subtype, in remission), or Substance use disorder (Mild subtype, in remission)
  • DSM-5 Personality Disorder other than Cluster B Personality disorders.
  • Positive urine drug screen for cocaine, opioids, amphetamine, and benzodiazepines at any visit
  • Antipsychotic medication or mood stabilizers taken within the last 30 days or change in antidepressant medication within the last 30 days.

Binge Eating Disorder Subjects:

  • DSM-5 diagnoses other than: Binge Eating Disorder (current bulimia also excluded), Tobacco Use Disorder, Major Depressive Disorder (in remission), Generalized Anxiety Disorder (in remission), Post-Traumatic Stress Disorder (in remission), and Substance Use Disorder (in remission, mild subtype).
  • DSM-5 diagnoses of Cluster B Personality disorders.
  • Positive urine drug screen for cocaine, opioids, amphetamine, and benzodiazepines at any visit

Stimulant Use Disorder, Cocaine Subtype Subjects:

  • DSM-5 diagnoses other than: Stimulant Use Disorder, Cannabis Use Disorder, Alcohol Use Disorder (Mild Subtype), and Tobacco Use Disorder, Substance Induced Mood Disorder, Major Depressive Disorder (in remission), Generalized Anxiety Disorder (in remission), Post-Traumatic Stress Disorder (in remission).
  • DSM-5 diagnoses of Cluster B Personality Disorders.
  • Positive urine drug screen for opioids, amphetamine, and benzodiazepines at any visit

ADHD Subjects:

  • DSM-5 diagnoses other than ADHD, Substance Induced Mood Disorder, Major Depressive Disorder (in remission), Generalized Anxiety Disorder (in remission), Post-Traumatic Stress Disorder (in remission), Substance Use Disorder (mild subtype, in remission).
  • DSM-5 diagnoses of Cluster B Personality Disorders.
  • Stimulant medication taken the morning of behavioral testing.
  • Positive urine drug screen for cannabis, cocaine, opioids, amphetamine, methamphetamine or benzodiazepines at any visit. Subjects with a valid prescription for amphetamines for the treatment of ADHD will not be excluded.
  • Unable or unwilling to withhold medications prescribed for treatment of ADHD on the morning of any behavioral testing clinic visit.
  • Further exclusion criteria apply
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722174


Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23219
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02722174     History of Changes
Other Study ID Numbers: 352.2073
First Submitted: March 23, 2016
First Posted: March 29, 2016
Last Update Posted: November 16, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Impulsive Behavior
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders